SWOG 2427: Single arm phase II study of bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant therapy in patients with muscle invasive bladder cancer (BRIGHT).
Phase II trial evaluates bladder preservation success with immunoradiotherapy after good response to neoadjuvant therapy in muscle invasive bladder cancer, suggesting a new approach.
Key Points
This trial aims to evaluate if certain patients with muscle invasive bladder cancer can avoid radical cystectomy after a positive response to neoadjuvant therapy.
Single arm, phase II trial design
Patients with clinically staged T2-T4aN0M0 muscle invasive bladder cancer receiving neoadjuvant therapy
Radiotherapy of 55 Gray delivered in 20 fractions with pembrolizumab for 1 year
Primary outcome: Target of 70% bladder intact event-free survival after 3 years in eligible patients
Secondary outcomes include local recurrence-free survival and metastasis-free survival
Toxicity assessments will monitor the safety of the combined treatment approach